CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report
Detachable Pend Fru-1 Pend component recalled by Mobius Imaging
Mobius Imaging is recalling Detachable Pend Fru-1 Pend component for the Airo Computed Tomography (CT) X-ray System, distributed nationwide in the US. The recall was initiated on 4 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1040-2026
- FDA event ID
- 98099
- Recalling firm
- Mobius Imaging, Shirley, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2025
- FDA classified
- 9 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Imaging Equipment
Timeline
| 4 Dec 2025 | Recall initiated by company | |
| 9 Jan 2026 | Classified by FDA | +36 days |
| 21 Jan 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Product as listed by the FDA
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Where it was distributed
US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaIllinoisKentuckyMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew YorkOhioPennsylvaniaRhode Island
Questions about this recall
Is Detachable Pend Fru-1 Pend component for the Airo Computed Tomography (CT) X-ray System recalled?
Yes. Mobius Imaging recalled Detachable Pend Fru-1 Pend component for the Airo Computed Tomography (CT) X-ray System on 4 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1040-2026.
Why was it recalled?
AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
Which lots are affected?
Part No. MI-76-0237; UDI: (01) 00869346000200 (11)230920 (21) AIRO-XXXX; Serial No. 2232206713, 2232206723, 2232206753, 2232206763, 2303430363, 2303430373, 2303430383, 2303430393, 2304034583, 2304034593, 2304034603, 2304034613, 2304034623, 2305514123, 2305514133, 2305514143, 2305514153, 2311019263, 2315101273, 2315101283, 2315101293, 2315101303, 2316030903, 2316030913, 2316703793, 2316703803, 2316703813, 2316703823, 2317415513, 2317415523, 2317415533, 2317415543, 2317415553, 2317905083, 2317905093, 2317905103, 2317905113, 2317905123, 2323513673, 2323513683, 2323513693, 2331419663, 2331419673, 2332117403, 2332117413, 2332117423, 2332117433, 2332117443, 2333404593, 2333404603, 2335506763, 2335506773, 2401909563, 2401909573, 2401909583, 2401909593, 2401909603, 2401909613, 2402911603, 2402911613, 2402911623, 2402911633, 2404302243, 2404302253, 2404302263, 2404302273, 2409620273, 2409620283, 2409620293, 2409620303, 2422207853, 2422207863, 2422207873, 2422207883, 2422207893, 2422207903, 2422207913, 2426303233, 2426303243, 2426303253, 2426303263, 2426303273, 2426303283, 2431210783, 2431210793, 2431210803, 2431210813, 2431210823, 2434504553, 2434504563, 2434504573, 2502103553, 2502103583, 2502103593, 2503121733, 2503121743, 2503121753, 2503616113, 2503616123, 2503616133, 2503616213.
Where was it sold?
US Nationwide distribution in the states of AK, AL, AZ, CA, CO, CT, DC, FL, IL, KY, MA, MD, MI, MN, MO, NC, NY, OH, PA, RI, SC, TN, TX, UT, VA, WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mobius Imaging
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Detachable Pendant Upgrade component recalled by Mobius Imaging | Mobius Imaging | Other | Nationwide |
| Device | CLASS II | MobiCT-32 AIRO Mobile CT Scanner recalled by Mobius Imaging | Mobius Imaging | Other | Nationwide |
| Device | CLASS II | MobiCT-32 AIRO Mobile CT Scanner recalled by Mobius Imaging | Mobius Imaging | Device Malfunction | CO, TN, UT |
| Device | CLASS II | AIRO Mobile CT System recalled by Mobius Imaging | Mobius Imaging | Device Malfunction | MA |
| Device | CLASS II | AIRO Mobile CT System recalled by Mobius Imaging | Mobius Imaging | Device Malfunction | Nationwide |
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